What side effects are associated with this type of intervention?

Higher protein intake in premature infants is generally aimed at promoting lean body mass development and potentially reducing body fat percentage. Common side effects of increased protein intake can include metabolic imbalances such as elevated blood urea nitrogen levels. Prebiotics and probiotics, often used to support gut health in premature infants, are generally well-tolerated but may pose risks such as bacterial translocation and systemic infections, particularly in those with immature gut barriers or compromised immune systems. Overall, these treatments are considered safe with careful monitoring.

What prior FDA approvals exist?

FDA approvals for the treatment of premature infants often focus on nutritional interventions to support growth and development. These include specialized formulas and supplements designed to meet the higher protein and caloric needs of preterm infants. While specific FDA-approved treatments similar to the higher protein intake study are not detailed in the provided context, it is common practice to use enriched formulas and parenteral nutrition to promote lean body mass development and potentially reduce body fat percentage in these vulnerable populations.

What other types of research exist?

Promising novel alternatives to higher protein intake for promoting lean body mass development and potentially reducing body fat percentage in premature infants include the use of prebiotics and probiotics. These have been shown to be safe and well-tolerated in infants, with potential benefits for gut health and nutrient absorption. Additionally, omega-3 fatty acids, particularly eicosapentaenoic acid (EPA), have shown benefits in other populations for improving body composition and could be considered for further research in premature infants.

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Protein Supplement

Protein Supplementation for Premature Infants

N/A

Waitlist Available

Led By Ariel A. Salas, MD, MSPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Necrotizing enterocolitis (NEC) stage 2 or greater

Gastrointestinal or neurologic malformations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth to 3 months of corrected age

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if adding extra protein to the milk of very premature babies helps them grow with less body fat. The special protein comes from cow's milk and is added to their usual fortified milk.

Who is the study for?

This trial is for extremely preterm infants born between 25 and 28 weeks of gestation who are being fed human milk and can handle feeding volumes of at least 120 ml/kg/day by the second week. Infants with severe intestinal disease (NEC stage 2+), life-limiting conditions, or malformations in the gut or nervous system cannot participate.

What is being tested?

The study is testing whether giving very premature babies more protein than usual in their diet will result in less body fat when they reach three months old. Babies will receive either standard or high levels of protein supplementation to see which affects body composition better.

What are the potential side effects?

While specific side effects are not detailed, increasing protein intake could potentially affect digestion, growth patterns, and metabolic processes in preterm infants. Close monitoring will help identify any adverse effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is NEC stage 2 or higher.

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I have abnormalities in my digestive system or nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth to 3 months of corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth to 3 months of corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 3 months of corrected age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Body mass index

Growth

Head circumference

+3 more

Other study objectives

Changes in intestinal microbiome

Changes in metabolic pathways

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High protein supplementationExperimental Treatment1 Intervention

Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.

Group II: Standard protein supplementationActive Control1 Intervention

Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Higher protein intake in premature infants, particularly those fed human milk, is believed to promote the development of lean body mass and potentially reduce body fat percentage. This is crucial for premature infants as they are at a higher risk of growth and developmental delays due to their early birth. Adequate protein intake supports muscle growth, organ development, and overall physical health, which are essential for improving both short-term and long-term clinical outcomes. Ensuring optimal nutrition through higher protein intake can help mitigate some of the challenges faced by preterm infants, aiding in their growth and reducing the risk of complications associated with low birth weight and prematurity.

Delayed introduction of progressive enteral feeds to prevent necrotising enterocolitis in very low birth weight infants.Feeding the preterm infant: opportunities and challenges of bringing science to the bedside.Arginine supplementation for prevention of necrotising enterocolitis in preterm infants.